Medicis Aesthetics, the manufacturer of Restylane, announced on October 11 that Restylane has now received FDA approval to be used for lip augmentation. Although Restylane has been used extensively for lip augmentation, doing so was considered an off-label indication. Restylane, a hyaluronic acid dermal filler, was first approved in 2005 for mid to deep dermal injection for the correction of moderate to severe facial wrinkles and folds, and has been used off-label for lip augmentation.
An FDA advisory panel had previously voted 6-0 with 1 abstention that the benefits of using Restylane as an injection for lip augmentation outweighed its risks, and that the filler was safe and effective for this indication. The panel reviewed the results of a study of 135 patients who received Restylane and 45 patients with no treatment. Almost all patients (99%) experienced adverse events, which included bruising, redness, swelling, pain, tenderness, itching, and skin exfoliation. Of those who were treated, 15% experienced adverse events (typically swelling and tenderness) that lasted more than 15 days.
Restylane and Juvederm are the most commonly utilized hyaluronic acid fillers in the United States. To learn more about treatments with Restylane and Juvederm, contact Dr. Jejurikar’s office at Dallas Plastic Surgery Institute at 214-827-2814.